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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, HHS.

# ACTION:

Notice.

# SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

# ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

## Epstein-Barr Negative Lymphoma-Derived Cell Lines

*Description of Technology:*                     The National Institutes of Health developed multiple lymphoid cell lines that were derived from patients with undifferentiated lymphoma of Burkitt's or non-Burkitt's type (now known as Burkitt and Burkitt-like lymphoma). Burkitt lymphoma is a highly aggressive B-cell lymphoma, which accounts for approximately half of all non Hodgkin's lymphomas in children. It also occurs in adults, and in some patients with compromised immune systems,                     *e.g.*, in patients infected with HIV. The cell lines have been used to advance our understanding of the molecular mechanisms of lymphomagenesis, and thus, can be used for the identification of molecular targets for drugs or other agents that can be developed for the treatment of lymphomas and other tumors.                

The Epstein-Barr virus (EBV) has been implicated in the pathogenesis of Burkitt lymphoma, although geographical variations occur. Ten out of sixteen cell lines derived at the NIH were found to be negative for Epstein-Barr virus (EBV), consistent with the low frequency of EBV association in this tumor in the USA. The cell lines were screened for chromosomal aberrations and fifteen were found to contain reciprocal translocation between chromosome 8 and 14, t(8;14). These exchanges involve the chromosomal regions on which the c-myc oncogene (8q24.1) and the heavy-chain immunoglobulin genes (14q32) reside.

*Applications:*                     (1) Screening tool to identify novel genes unique to or overexpressed in Burkitt lymphoma; (2) Screen for compounds that kill tumor cells and represent potential therapeutic agents; (3) Control in screening for novel genes expressed or overexpressed in EBV + Burkitt lymphoma; (4) Control for therapeutic agents directed against EBV genes or genes induced by EBV                

*Inventor:*                     Ian Magrath (NCI)                

*Publications:*                     1. IT Magrath, et al., “Characterization of lymphoma-derived cell lines: comparison of cell lines positive and negative for Epstein-Barr virus nuclear antigen. I. Physical, cytogenetic, and growth characteristics.” J Natl Cancer Inst. 1980 March; 64(3):465-476.                

2. IT Magrath, et al., “Characterization of lymphoma-derived cell lines: Comparison of cell lines positive and negative for Epstein-Barr virus nuclear antigen. II. Surface markers.” J Natl Cancer Inst. 1980 Mar; 64(3):477-483.

*Patent Status:*                     HHS Reference No. E-221-2006/0—Research Tool.                

*Licensing Status:*                     Available for licensing under a biological material license.                

*Licensing Contact:*                     John Stansberry, PhD; 301/435-5236;                     *stansbej@mail.nih.gov*.                

## Organic Thiophosphate Antiretroviral Agents

*Description of Technology:*                     The current technology represents a potentially safe and effective addition to the antiretroviral drug combinations used for treatment of HIV infection. Amifostine, phosphonol and functional derivatives thereof are available for licensing and commercial development for use as antiretroviral drugs. These organic thiophosphate reducing agents inhibit HIV viral growth and protein expression in HIV-infected human white blood cells without destroying the cells. The compounds described in this technology block growth of HIV by a mechanism that is dependent on the level of aminothiol reducing agent in the cellular environment. In addition, a range of effective doses and methods for oral administration of the available organic thiophosphates is provided.                

*Applications:*                     (1) Novel therapeutics for the treatment of HIV infection; (2) Safe and effective addition to the drug combinations currently used to treat HIV/AIDS.                

*Market:*                     (1) Nearly 40.3 million people living with HIV worldwide, including approximately 2.0 million people in North America and Europe; (2) Anti-HIV/AIDS therapeutics experience accelerated market acceptance and draw revenues of approximately $240 million to $1 billion.                

*Development Status:*                     Preclinical data is available at this time.                

*Inventors:*                     Miriam C. Poirier (NCI), Gene M. Shearer (NCI), et al.                

*Related Publications:*                     1. T Kalebic and PS Schein. Organic thiophosphate WR-151327 suppresses expression of HIV in chronically infected cells. AIDS Res Hum Retroviruses. 1994 Jun; 10(6):727-733.                

2. JL Rossio, MT Esser, K Suryanarayana, DK Schneider, JW Bess Jr, GM Vasquez, TA Wiltrout, E Chertova, MK Grimes, Q Sattentau, LO Arthur, LE Henderson, JD Lifson. Inactivation of human immunodeficiency virus type 1 infectivity with preservation of conformational and functional integrity of virion surface proteins. J Virol. 1998 Oct; 72(10):7992-8001.

3. CF Perno, R Yarchoan, DA Cooney, NR Hartman, S Gartner, M Popovic, Z Hao, TL Gerrard, YA Wilson, DG Johns, et al. Inhibition of human immunodeficiency virus (HIV-1/HTLV-IIIba-L) replication in fresh and cultured human peripheral blood monocytes/macrophages by azidothymidine and related 2′,3′-dideoxynucleosides. J Exp Med. 1988 Sep 1; 168(3):1111-1125.

4. LS Clark, RJ Albertini, JA Nicklas. The aminothiol WR-1065 protects T lymphocytes from ionizing radiation-induced deletions of the HPRT gene. Cancer Epidemiol Biomarkers Prev. 1997 Dec; 6(12):1033-1037.

5. NP Nguyen, B Levinson, S Dutta, U Karlsson, KC Kelly, J Dowell, A Ludin, S Sallah. Amifostine and curative intent chemoradiation for compromised cancer patients. Anticancer Res. 2003 Mar-Apr; 23(2C):1649-1656.

*Patent Status:*                     U.S. Provisional Application No. 60/792,431 filed 17 Apr 2006 (HHS Reference No. E-017-2006/0-US-01).                

*Licensing Status:*                     Available for non-exclusive or exclusive licensing.                

*Licensing Contact:*                     Sally Hu, PhD; 301/435-5606;                     *HuS@mail.nih.gov*.                

*Collaborative Research Opportunity:*                     The National Cancer Institute Laboratory of Cellular Carcinogenesis and Tumor Promotion is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or                           ( print page 55498)                        commercialize these organic thiophosphate antiretroviral agents. Please contact Betty Tong, PhD at 301/594-4263 or                     *tongb@mail.nih.gov*                     for more information.                

Dated: September 18, 2006.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

[FR Doc. 06-8082 Filed 9-21-06; 8:45 am]

BILLING CODE 4140-01-P